• Regulatory Affairs
  • Active ingredients and excipients

Active ingredients and excipients

No marketing authorisation/registration of medicinal products is issued without submitting dossiers on active ingredients and excipients.

The competent authorities require comprehensive active-ingredient documentation that takes into account the extensive national and international regulations.

We have prepared, updated and evaluated numerous active-ingredient dossiers (ASMF, CEP, US-DMF) and dossiers on excipients (CEP and US-DMF). These include:

  • Chemical active ingredients
  • Biological active ingredients
  • Plant extracts/herbal active ingredients
  • All excipients

Have confidence in our long-standing expertise: we offer advice during the excipient or active-ingredient development process and support when compiling and evaluating documentation for your dossier.

Dr. Verena Peter
Quality/CMC

Phone: +49 89 2000203-71
Email:

Bettina Rankl
Quality/CMC

Phone: +49 89 2000203-51
Email:

Contact us. We’re happy to help!

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+49 7272 7767-0